EP0911032A1 - Compositions effervescentes contenant des extraits végétaux - Google Patents

Compositions effervescentes contenant des extraits végétaux Download PDF

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Publication number
EP0911032A1
EP0911032A1 EP97118648A EP97118648A EP0911032A1 EP 0911032 A1 EP0911032 A1 EP 0911032A1 EP 97118648 A EP97118648 A EP 97118648A EP 97118648 A EP97118648 A EP 97118648A EP 0911032 A1 EP0911032 A1 EP 0911032A1
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EP
European Patent Office
Prior art keywords
parts
weight
plant extract
effervescent
preparation according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP97118648A
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German (de)
English (en)
Other versions
EP0911032B2 (fr
EP0911032B1 (fr
Inventor
Gerhard Dr. Gergely
Imgard Gergely
Thomas Dr. Gergely
Stefan Dr. Gergely
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dr Gergely and Co
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8227525&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0911032(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Priority to AT97118648T priority Critical patent/ATE214285T1/de
Priority to DE59706616T priority patent/DE59706616D1/de
Priority to ES97118648T priority patent/ES2173364T5/es
Priority to EP97118648A priority patent/EP0911032B2/fr
Priority to CA002250524A priority patent/CA2250524A1/fr
Priority to TR1998/02123A priority patent/TR199802123A3/tr
Priority to BRPI9804055-3A priority patent/BR9804055B1/pt
Priority to US09/178,639 priority patent/US6190697B1/en
Priority to PL329460A priority patent/PL191658B1/pl
Publication of EP0911032A1 publication Critical patent/EP0911032A1/fr
Publication of EP0911032B1 publication Critical patent/EP0911032B1/fr
Application granted granted Critical
Publication of EP0911032B2 publication Critical patent/EP0911032B2/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents

Definitions

  • the invention relates to a shower preparation according to the preamble of the claim 1 .
  • Plant extracts have always been a popular dosage form Prophylaxis and therapy; last but not least, they gain from increasing information the mechanism of action and structure of the active ingredients in importance.
  • instant tea has been required for higher doses the most important dosage form, but which has some disadvantages, namely on the one hand the inexact dosage by dissolving a tea or tablespoon of the Instant teas in water, whereby the filling quantity can hardly be kept exactly can; on the other hand, they are - usually in powder or granule form - Plant extract instant teas very hygroscopic and bale or clump in the container after opening it a few times.
  • the aim of the invention was therefore a galenical preparation for easily soluble Plant extracts in the form of an effervescent tablet to create a dissolution time less than 4 minutes and has significantly reduced foaming.
  • the invention is based on the plant extract having at least one fatty, treat oily or waxy substance, especially a thin one Coating film of this substance or substances on the plant extract particles to generate, this hydrophobic extract phase with greasy, oily or wax-like substances preferably also emulsifiers are added.
  • the greasy, oily or waxy substances can either be in melted State or dissolved in a solvent in which the emulsifiers are soluble, to which plant extract particles are applied.
  • the on this Plant extracts treated in this way can then be added, if necessary Emulsifier additive - added to an effervescent granulate and the mixture Tablets are pressed. You get effervescent tablets with plant extracts, which dissolve in water at 17 ° C within 11 ⁇ 2 to 4 minutes.
  • the plant extracts sufficiently hydrophobic to make the effervescent tablet Dissolution in water does not gelatinize, so the effectiveness of the shower particles if water comes in, comes into play as desired and thereby a rapid dissolution of the tablet is made possible.
  • the effervescent particles unfold their effervescent activity and the plant extract particles in the water become from the tablet - due to the hydrophobic structure - thrown out due to the effervescent effect and only dissolve afterwards on.
  • esters of medium-chain, vegetable fatty acids such as. B. caprylic and capric acid, with glycerol or propylene glycol, preferably Miglyol® neutral oils.
  • Fats are used. It is mainly triglycerides that are essentially from mixtures of glycerol esters of higher fatty acids, especially vegetable or of animal origin, with a chain length of about 10 to 22 carbon atoms, consist. These include, for example, microcrystalline triglycerides and glycerol esters saturated, straight and unbranched fatty acids, e.g. Glyceryl trimyristates, Glyceryl tripalmitates, trimyristine, etc. Other suitable fat components are z. B. coconut oil, hardened coconut oil, hydrogenated castor oils, tocopherol acetate, Esters of higher fatty acids such as B. isopropyl palmitate, polyethylene glycols, such as. Carbowax®, depending on the plant extract Carbowax® 400 or Carbowax® 6000 can also be used.
  • the fatty, oily or waxy substances are in an amount of 0.5 to 25 parts by weight, preferably 0.8-19 parts by weight, based on 100 Parts by weight of the easily soluble plant extract used, these substances are at least partially contained in the plant extract phase, however can also be added to the effervescent granules as a separate fat phase.
  • the emulsifiers are combined with the greasy, oily ones or waxy substances applied directly to the plant extract and optionally added on the other hand in the form of a phase, the emulsifiers be applied to a carrier with suitable solvents Evaporated solvent and mixed this emulsifier phase to the effervescent tablet becomes.
  • emulsifiers can be used.
  • Recommendable are phospholipids such as lecithin, metharin, epicuron, and also polysorbates (Sorbitan monolaurate, etc.) and ethoxylated glycerol fatty acid esters (e.g. Tagate®), sugar esters, glycerin-polyethylene glycol oxystearate (Cremophor RH 40), Macrogol glycerol ricinoleate or sodium stearyl lactate. It can too Wetting agents such as sodium dioctysulfosuccinate or sodium lauryl sulfate are used become.
  • emulsifiers in the plant extract phase incorporated and / or additionally in a further emulsifier phase Final mixture for the ready-to-press granules are added.
  • the amount of emulsifier is between 0.2 and 10, preferably 0.3 - 8 parts by weight to 100 parts by weight of the easily soluble plant extract used, where also some emulsifiers due to their oily property the effectiveness of the reinforce fatty substances, or some lipids also emulsifier character have, such as propylene glycol stearate, glycerol oleate, laurate and stearate ..
  • a fine filler can be added, which clings to the greasy surface and thus clumps the Active ingredient phase prevented.
  • All common pharmaceutical tablet fillers come for this such as sugar alcohols, mannitol, sorbitol, maltodextrin, powdered sucrose, powdered lactose, fructose, glucose, etc. These fillers can be introduced directly into the plant extract phase (see example 1), or the plant extract phase is made after production homogeneously mixed with a filler and then with the effervescent granules mixed with the remaining ingredients, flavors etc.
  • mannitol or sorbitol takes part of the oily, fatty, or waxy Substance as well as the emulsifiers and prevents clumping the coated grains of the plant extract phase. Otherwise they are fillers mentioned also as carriers for the emulsifier (s), for the or the anti-foaming agents, as well as for any additional quantities of the oily, greasy or wax-like substance, especially if the absorption capacity of the plant extract particles for these substances on the surface not enough to achieve the optimal effect.
  • the plant extract phase can be produced as follows: The easily soluble plant extracts are warmed to 45 to 60 ° C; a solution or melt the greasy, oily or waxy substances - preferably with one or more emulsifiers - is applied. This solution are allowed to distribute evenly with stirring and then evaporated the solvent, preferably by means of vacuum. Before drying can still the fillers are added.
  • an anti-foaming agent must be added to the fat emulsifier phase can be introduced, but on the other hand also as separate Phase to a mixture of the effervescent granules and the plant extract phase can be added, the anti-foaming agent on a neutral auxiliary or Filler is pulled up.
  • the anti-foaming agent is by means of a solvent or an aqueous Suspension suspended on a filler; the solvent is evaporated, and this phase is added to the tablet.
  • the amount of anti-foaming agent introduced based on 100 parts by weight of the plant extract, can be between 0 and 10 parts by weight, i.e. that with low saponin-containing, easily soluble plant extracts in special If the use of an anti-foaming agent is not necessary.
  • oily, greasy or waxy substance as well any emulsifiers and / or anti-foaming agents that may be provided the intended for the production of the plant extract for spray drying Add solution.
  • the acid component preferably consisting of citric acid, tartaric acid, malic acid, or from their salts, such as, for. B. monosodium citrate or monosodium tartrate.
  • the base portion of the effervescent base expediently consists of alkali bicarbonates or carbonates which release CO 2 , such as sodium and / or potassium bicarbonate or carbonate, and partly, but not exclusively, of alkaline earth carbonates, such as calcium carbonate and / or magnesium carbonate.
  • sweeteners such as sugar, Sodium cyclamate, saccharin sodium, aspartame, acesulfame, and flavorings or other pharmaceutical fillers, such as sugar alcohols, e.g. B. Mannitol and Sorbitol, and also maltodextrin, optionally sucrose, fructose, lactose, etc. find use.
  • sugar alcohols e.g. B. Mannitol and Sorbitol
  • maltodextrin optionally sucrose, fructose, lactose, etc.
  • the plant extract effervescent preparation produced according to the invention draws rapid dissolution in water (dissolution time at 17 ° C: 11 ⁇ 2 to 4 Minutes) and a significantly improved foaming behavior, i.e. little Foam out.
  • Example 1 Ivy extract effervescent tablet
  • ivy dry extract 65 parts by weight of ivy dry extract are heated to about 45 - 50 ° C.
  • the dry extract is mixed with a solution of 5 parts by weight of simethicone, 2 Parts by weight of caprylic capric acid trigliceride (Miglyol 812®), 0.2 parts by weight Tagat® R40 (ethoxylated glycerol fatty acid ester), in 1.7 parts by weight of butanone and 0.7 parts by weight of ethanol treated 96%.
  • This solution is omitted Distribute stirring on the ivy dry extract and add 100 before drying Parts by weight of mannitol.
  • the product is then placed under vacuum dried slowly and the phase was sieved to 0.5 mm.
  • the effervescent granules are made with the following ingredients and quantities: 1165 parts by weight of citric acid crystalline, 250 parts by weight of citric acid Powder, 3 parts by weight of saccharin sodium and 50 parts by weight of sodium cyclamate were heated to 60 ° C and with a solution of 5 parts by weight of sodium citrate and 5.5 parts by weight of water are moistened. Then you add 897 parts by weight of sodium hydrogen carbonate and reacted in a controlled manner. Before drying, 88 parts by weight of sodium carbonate are added and the mixture is dried the product is then vacuumed at a temperature above 50 ° C up to 15 mbar.
  • 172.2 parts by weight of the plant extract phase are used for the press-ready granules with 2458 parts by weight of a shower base and 200 parts by weight Sorbitol, 298 parts by weight of mannitol and with 60 parts by weight of flavor as well 210 parts by weight of maltodextrin mixed and compressed into tablets of 3.4 g.
  • a fruit powder can also be used for flavoring On the order of 250 to 270 parts by weight can be added.
  • the product shows low foaming and a dissolution time of 21 ⁇ 2 to maximum 3 minutes, with a comparable effervescent tablet without treated Plant extract shows a dissolution time of 5 to 7 minutes.
  • Examples 2 to 17 with further easily soluble plant extracts are listed in Tables 1 to 4 below, the preparation essentially corresponding to the preparation of Example 1.
  • Solidago and birch leaf extracts are both high in saponin but require nevertheless a different fat and emulsifier phase. While with the birch leaves preferably Carbowax 400 as a fatty substance and metharin (a Phospholipid) can be used as an emulsifier in Solidago extract Miglyol as the fatty substance and sorbitan mono-isostearate as the emulsifier are the best Results shown. In these examples, in addition to foam formation also the dissolution properties to bear, i.e. with birch leaf extract priority is given to foam control, since the birch leaf extracts have not prolonged the dissolution time as much as it did with the Solidago is the case.
  • the Solidago extract stands next to the foam control primarily the reduction of the dissolution time from almost 20 minutes to less than 4 minutes in the foreground what will be caused by the measure described could. Almost every extract has - due to the respective large number of ingredients - a very own behavior, so that the optimum based on the given Information needs to be set each time.
  • Effervescent tablets that have not been treated or manufactured according to the invention, begin to shower in the water at the surface; the effervescent effect and with that the dissolution are increasingly due to the formation of a highly concentrated, sticky-slimy solution between the shower granules slowed down. This will prevent water from entering the core of the effervescent tablet prevented so that it stays dry and the resolution accordingly slow he follows.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Botany (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medical Informatics (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Organic Chemistry (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Compounds Of Unknown Constitution (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Cosmetics (AREA)
EP97118648A 1997-10-27 1997-10-27 Compositions effervescentes contenant des extraits végétaux Expired - Lifetime EP0911032B2 (fr)

Priority Applications (9)

Application Number Priority Date Filing Date Title
AT97118648T ATE214285T1 (de) 1997-10-27 1997-10-27 Brausezubereitung mit pflanzenextrakt
DE59706616T DE59706616D1 (de) 1997-10-27 1997-10-27 Brausezubereitung mit Pflanzenextrakt
ES97118648T ES2173364T5 (es) 1997-10-27 1997-10-27 Composicion efervescente con extracto vegetal.
EP97118648A EP0911032B2 (fr) 1997-10-27 1997-10-27 Compositions effervescentes contenant des extraits végétaux
CA002250524A CA2250524A1 (fr) 1997-10-27 1998-10-15 Preparation effervescente renfermant un extrait de plante
TR1998/02123A TR199802123A3 (tr) 1997-10-27 1998-10-22 Bitki özlü efervesan tabletin hazirlanisi.
BRPI9804055-3A BR9804055B1 (pt) 1997-10-27 1998-10-23 formulação efervescente com extrato de plantas e processos para preparação de fase de extrato vegetal e de fase de substáncia de enchimento.
US09/178,639 US6190697B1 (en) 1997-10-27 1998-10-26 Effervescent formulation containing plant extract
PL329460A PL191658B1 (pl) 1997-10-27 1998-10-27 Preparat musujący w postaci granulatu lub tabletek, sposób otrzymywania fazy ekstraktu roślinnego dla preparatu musującego, oraz sposób otrzymywania fazy wypełniacza dla preparatu musującego

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP97118648A EP0911032B2 (fr) 1997-10-27 1997-10-27 Compositions effervescentes contenant des extraits végétaux

Publications (3)

Publication Number Publication Date
EP0911032A1 true EP0911032A1 (fr) 1999-04-28
EP0911032B1 EP0911032B1 (fr) 2002-03-13
EP0911032B2 EP0911032B2 (fr) 2004-09-01

Family

ID=8227525

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97118648A Expired - Lifetime EP0911032B2 (fr) 1997-10-27 1997-10-27 Compositions effervescentes contenant des extraits végétaux

Country Status (9)

Country Link
US (1) US6190697B1 (fr)
EP (1) EP0911032B2 (fr)
AT (1) ATE214285T1 (fr)
BR (1) BR9804055B1 (fr)
CA (1) CA2250524A1 (fr)
DE (1) DE59706616D1 (fr)
ES (1) ES2173364T5 (fr)
PL (1) PL191658B1 (fr)
TR (1) TR199802123A3 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1027039A4 (fr) * 1997-10-31 2001-09-12 Farmo Nat Ltd Granules effervescents
EP1196043A4 (fr) * 1999-06-29 2002-11-05 Xel Herbaceuticals Preparation effervescente d'extrait de the vert
WO2003061630A1 (fr) * 2002-01-21 2003-07-31 Galenica Ab Procede servant a preparer des comprimes
WO2004048505A1 (fr) * 2002-11-21 2004-06-10 S. C. Johnson & Son, Inc. Compositions effervescentes

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6974595B1 (en) * 1996-05-17 2005-12-13 Proethic Pharmaceuticals, Inc. Pharmaceutical compositions based on Diclofenae
US20030091629A1 (en) * 1998-03-27 2003-05-15 Cima Labs Inc. Sublingual buccal effervescent
US6974590B2 (en) * 1998-03-27 2005-12-13 Cima Labs Inc. Sublingual buccal effervescent
ITMI20020754A1 (it) 2002-04-09 2003-10-09 Aboca S P A Composizioni effervescenti contenenti succhi di frutta essicati
EP1708686B1 (fr) * 2003-12-31 2011-02-16 Cima Labs Inc. Forme galenique de fentanyl generalement lineaire effervescente et orale et ses procedes d'administration
US7858121B2 (en) * 2003-12-31 2010-12-28 Cima Labs, Inc. Effervescent oral fentanyl dosage form and methods of administering fentanyl
DE602004031771D1 (de) * 2003-12-31 2011-04-21 Cima Labs Inc Brauseformen von opiaten zur oralen anwendung und verfahren zur verabreichung von oxycodon
DE102010021842A1 (de) * 2010-05-28 2011-12-01 Bionorica Se Thymian/Primel oder Efeu zur Behandlung von chronischobstruktiven Lungenerkrankungen (COPD)
WO2012047205A1 (fr) * 2010-10-05 2012-04-12 University Of Tennessee Research Foundation Compositions cosmétiques comprenant des nanoparticules dérivées du lierre
EP2662086A1 (fr) * 2012-05-08 2013-11-13 Progressare Medinvest B.V. Composition pour le traitement ou la prévention des infections des voies urinaires et forme galénique
CA3018828C (fr) 2014-09-17 2021-05-11 Steerlife India Private Limited Composition effervescente et son procede de fabrication
WO2017098481A1 (fr) 2015-12-12 2017-06-15 Steerlife India Private Limited Compositions effervescentes de metformine et leurs procédés de préparation
US11261409B2 (en) * 2019-04-19 2022-03-01 One Home Brands, Inc. Tablet production

Citations (2)

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Publication number Priority date Publication date Assignee Title
WO1990003179A1 (fr) * 1988-09-22 1990-04-05 Stephan Guenter Comprime effervescent
WO1997029642A1 (fr) * 1996-02-15 1997-08-21 Eulogio Mas Criado Pastille effervescente obtenue a partir d'un extrait concentre d'infusion a base de plantes aromatiques

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US4127645A (en) * 1976-05-21 1978-11-28 Life Savers, Inc. Effervescent tablet and method
US5219574A (en) * 1989-09-15 1993-06-15 Cima Labs. Inc. Magnesium carbonate and oil tableting aid and flavoring additive
US5633004A (en) * 1991-03-25 1997-05-27 Showa Denko K.K. Granular agent for ruminants and process for producing the same
US5415870A (en) * 1991-07-01 1995-05-16 Gerhard Gergely Effervescent systems using reaction doping agents
US5262162A (en) * 1991-09-06 1993-11-16 Merz & Co. Gmbh & Co. Cerebral-activating extract
DE19509856C2 (de) † 1995-03-17 1997-09-11 Schwabe Willmar Gmbh & Co Verwendung einer Brausezusammensetzung mit Ginkgo-Biloba Trockenextrakt zur Behandlung peripherer und cerebraler Durchblutungsstörungen

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990003179A1 (fr) * 1988-09-22 1990-04-05 Stephan Guenter Comprime effervescent
WO1997029642A1 (fr) * 1996-02-15 1997-08-21 Eulogio Mas Criado Pastille effervescente obtenue a partir d'un extrait concentre d'infusion a base de plantes aromatiques

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 9739, Derwent World Patents Index; AN 97-424658 [39], XP002060147 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1027039A4 (fr) * 1997-10-31 2001-09-12 Farmo Nat Ltd Granules effervescents
EP1196043A4 (fr) * 1999-06-29 2002-11-05 Xel Herbaceuticals Preparation effervescente d'extrait de the vert
JP2003503324A (ja) * 1999-06-29 2003-01-28 イクセル・ハーバシューティカルズ 発泡性緑茶抽出物製剤
WO2003061630A1 (fr) * 2002-01-21 2003-07-31 Galenica Ab Procede servant a preparer des comprimes
US7422757B2 (en) 2002-01-21 2008-09-09 Galencia Ab Tabletting process
WO2004048505A1 (fr) * 2002-11-21 2004-06-10 S. C. Johnson & Son, Inc. Compositions effervescentes

Also Published As

Publication number Publication date
BR9804055A (pt) 2000-05-16
PL329460A1 (en) 1999-05-10
ES2173364T3 (es) 2002-10-16
TR199802123A2 (xx) 1999-05-21
CA2250524A1 (fr) 1999-04-27
TR199802123A3 (tr) 1999-05-21
EP0911032B2 (fr) 2004-09-01
US6190697B1 (en) 2001-02-20
DE59706616D1 (de) 2002-04-18
PL191658B1 (pl) 2006-06-30
ATE214285T1 (de) 2002-03-15
EP0911032B1 (fr) 2002-03-13
ES2173364T5 (es) 2005-04-16
BR9804055B1 (pt) 2009-05-05

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